# QA Specialist - Investigation and CAPA
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
We are searching for the best talent for a QA Specialist- Investigation and CAPA to be located in Gurabo, PR.
The Quality Specialist (Investigations & CAPA) ensures that the Investigations and CAPA's Quality System is maintained in compliance with established company and corporate standard operating procedures, policies, rules, regulations, and current GMP guidelines.
You will be responsible for:
•Evaluate and approve records for Quality Investigations and Corrective Actions and Preventive Actions (CAPA).
•Collaborate with other J&J affiliates and JSC functions, and handle complaints from other J&J affiliates regarding products manufactured at the site. Coordinate strategies for investigation management.
•Support QA oversight of the Quality Investigations and CAPAs system by monitoring performance, and report metrics.
•Assist in regulatory inspections and ensure appropriate closure of any outstanding GMP issues from internal and external audits.
•Provide feedback and review procedures, protocols, and other documents related to Quality Investigations and CAPAs.
•Escalate compliance issues to the Quality Manager for Investigations and CAPAs.
Qualifications
Education:
•A minimum of a Bachelor's degree is required or Bachelor of Engineering degree in Chemistry, Biology, Biochemistry, Microbiology, Engineering, Mathematics, or a related science is preferred.
Experience and Skills:
•A minimum of two (2) years of experience in related areas, such as management of investigations and CAPA processes, in the pharmaceutical industry.
•Experience related to parenteral manufacturing areas or biological manufacturing (preferred).
•Expert understanding of cGMP, Good Documentation Practices, and Regulations.
•Familiarity with US and International GMPs for pharmaceuticals.
•Good oral and written communication skills in both English and Spanish, including proficiency in technical writing.
Other:
•ASQ Certified Quality Auditor desirable.
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
